Device Recall DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS

  • Model / Serial
    Lot Code: 17800601.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution (AL, OH, MN, NM, and CA).
  • Product Description
    Duracon Total Knee, A-P Lipped Tibial Insert; 11MM || Sterile; Howmedica Osteonics Corp. || Stryker, Ireland. Product No. 6642-1-611. || The device is used to replace bearing surface if the proximal tibia in order to relieve pain, instability and/or restriction of motion due to degenerative joint disease, failed previous prosthesis or trauma. The tibial inserts are designed to accommodate the posterior cruciate ligament if it is present. These components are intended for implantation with bone cement only.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430
  • Manufacturer Parent Company (2017)
  • Source
    USFDA